Abstract
Purpose: Cancer-related fatigue (CRF) is a common and debilitating symptom in palliative care, with limited effective treatments. This study evaluated the efficacy and safety of K-style contact needle technique (CNT), a non-invasive form of traditional Japanese acupuncture, for alleviating CRF. Methods: In this multicenter, single-blind randomized controlled trial, 119 patients with stage III or IV cancer and moderate to severe fatigue (≥ 4 on a Numerical Rating Scale [NRS]) were randomized to receive either CNT or sham CNT weekly for 4 weeks. The primary outcome was change in fatigue NRS scores. Secondary outcomes included the Cancer Fatigue Scale (CFS), Support Team Assessment Schedule-Japanese version (STAS-J), Palliative Prognostic Index (PPI), Palliative Performance Scale (PPS), salivary amylase activity (SAA), and adverse events. Results: Although no significant difference was observed in the primary outcome between groups by t test, multiple regression analysis at Week 4 revealed a significant treatment effect for CNT (β = 1.548, p = 0.029). CNT also improved STAS-J scores (β = 1.758, p = 0.044) and reduced SAA at Week 2 and final evaluation (p < 0.05). No serious adverse events occurred. Conclusions: CNT may be a safe, gentle, and potentially effective intervention for managing fatigue and distress in palliative care patients with advanced cancer. Further research is warranted to confirm these findings and assess long-term outcomes. Trial registration: UMIN000028304, registered on July 21st, 2017; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032401.